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Corneal newvessels may arise from a fan of pathologies, inducing long-standing corneal opacification requiring keratoplasty. These last years, VEGF inhibitors have been designed to reduce newascularization induced by gastric cancer or age-related macular degeneration. A few reports have been published showing the interest of VEGF inhibitors to treat corneal newvessels, but no randomized study has been achieved to date.
This study is designed to assess the efficacy of Bevacizumab, a VEGF inhibitor monoclonal antibody, to reduce the surface of corneal newvessels in when compared to placebo
This study will involve 42 outpatients of the CHU of Limoges, Bordeaux, and Toulouse, addressed for corneal pathologies including corneal newvessels. The patients will be randomly assigned to two groups, one receiving three subconjunctival injections of bevacizumab, the other three subconjunctival injections of placebo (Balanced salt solution). The progression of newvessels will be assessed using color photographs and a picture-analyser software that will calculate the percentage of corneal surface occupied by the newvessels. Randomization, and preparation of both study drug and placebo syringes will be performed by the central pharmacy of the CHU de Limoges. Patients will be followed-up as outpatients, with visits scheduled 15 days before treatment, at baseline, and then at 1 month, 2 months, 3 months, and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bevacizumab | Experimental | Three subconjunctival injections of 0.5 ml of bevacizumab at inclusion, 1 month, 2 month. |
|
| Placebo | Placebo Comparator | Three subconjunctival injections of 0.5 ml of Nacl at inclusion, 1 month, 2 month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Drug | Three subconjunctival injections of 0.5 ml of bevacizumab at: inclusion, 1 month, 2 month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neovascularisation reduction at 3 months | Assessement using color photographs and a picture-analyser software that will calculate the percentage of corneal surface occupied by the newvessels at 3 months. A reduction of 30% is target. | at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Local and general toxicity of bevacizumab | Safty data are collected at each visit either by clinical examination or by patient questionnary | at 1 months, 2 month, 3 month, 6 month |
| Efficacy at 6 months |
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Inclusion Criteria:
inclusion criteria:
Exclusion Criteria:
Patients who received local or general treatment of concomitant prostaglandin derivatives
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Ophtalmologie | Limoges | 87042 | France | |||
| CHU Poitiers-Ophtalmologie |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| NaCl | Drug | Three subconjunctival injections 0.5 ml placebo (Balanced salt) solution at inclusion, 1 month, 2month |
|
Assessed using color photographs and a picture-analyser software that will calculate the percentage of corneal surface occupied by the newvessels at 6 month
| at 6 month |
| Poitiers |
| 86021 |
| France |
| CHU St Etienne | Saint-Etienne | France |
| CHU Strasbourg- Service Ophtalmlogie | Strasbourg | 67000 | France |
| CHU de Toulouse, Service d'Ophtalmologie | Toulouse | 31059 | France |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |